In a show­down with As­traZeneca, Pfiz­er posts sol­id — and very fa­mil­iar — PhI­II breast can­cer da­ta for ta­la­zoparib

Jen­nifer Lit­ton, MD An­der­son Can­cer Cen­ter

Pfiz­er $PFE came through with pos­i­tive num­bers for its Phase III study of its PARP in­hibitor ta­la­zoparib in ad­vanced breast can­cer — lin­ing up right along­side As­traZeneca’s $AZN lead­ing ri­val Lyn­parza. And the re­sults po­si­tion Pfiz­er to join the PARP line­up as the fourth play­er to toe up to the mar­ket thresh­old — though maybe not in the lead po­si­tion it was promised when the phar­ma gi­ant bought the drug last year.

An­a­lysts have been wait­ing to see how Pfiz­er’s drug, bagged in the $14 bil­lion ac­qui­si­tion of Medi­va­tion, will fare rel­a­tive to the com­pe­ti­tion. It’s a wide­ly frowned on ap­proach by the ex­perts, but mar­ket an­a­lysts love to match up da­ta from two dif­fer­ent stud­ies of the same dis­ease, of­fer­ing caveats on what could be im­por­tant dis­tinc­tions in tri­al de­signs, pa­tient pop­u­la­tions and end­points.

In this case, which begs for a com­par­i­son, the num­bers are close enough to Lyn­parza’s read­out ear­li­er in the year that it will like­ly em­pha­size just how com­pa­ra­ble these ther­a­pies can be, in­clud­ing the com­pe­ti­tion at Tesaro $TSRO (Ze­ju­la) and Clo­vis $CLVS (Rubra­ca).

Pfiz­er’s re­searchers con­clud­ed that there was a 45.8% re­duc­tion in the risk of dis­ease pro­gres­sion in the EM­BRA­CA study, which re­cruit­ed women with HER2-neg­a­tive breast can­cer with germline BR­CA mu­ta­tion. Me­di­an PFS was 8.6 months, com­pared to 5.6 months in the con­trol arm.

The over­all re­sponse rate was 62.6% in the drug arm com­pared with on­ly 27.2% in the con­trol. There were al­so 12 com­plete re­spons­es — no vis­i­ble signs of the dis­ease — for ta­la­zoparib, com­pared to none in con­trol.

“Most no­table for this study was not on­ly the im­prove­ment to date of PFS, but the time to clin­i­cal de­te­ri­o­ra­tion, which was 24.3 months for pa­tients on ta­la­zoparib, ver­sus 6.3 months for those on stan­dard-of-care chemother­a­py,” MD An­der­son’s Jen­nifer Lit­ton not­ed.

Com­pare that to Lyn­parza’s 42% re­duc­tion in the risk of pro­gres­sion, a 7-month ver­sus 4.2-month PFS — or a gap of 2.8 months ver­sus 3 months for ta­la­zoparib — and a 59.9% ta­la­zoparib vs 28.8% chemo ORR.

Both stud­ies com­pared their drug against stan­dard of care chemo.

For­mer Medi­va­tion CEO David Hung sold this drug hard in dri­ving the deal to sell his com­pa­ny to Pfiz­er for $14 bil­lion last year, claim­ing it was clear­ly su­pe­ri­or to every­thing out there. That would be an even hard­er sales job to­day, with the late-stage da­ta on dis­play.

Michael Schmidt didn’t see much day­light be­tween what Pfiz­er and As­traZeneca have on of­fer, and he con­sid­ers that a plus for Clo­vis.

Ta­la­zoparib was pre­vi­ous­ly tout­ed as po­ten­tial “best-in-class” PARP in­hibitor and most po­tent “PARP trap­per”. That said, at least based on the pre­lim­i­nary da­ta dis­closed in PFE’s (MP)press-re­lease this morn­ing, re­sults in breast can­cer look rather sim­i­lar to AZN’s (MP) OLYMPIAD tri­al re­sults of Lyn­parza which were pre­sent­ed ear­li­er this year at AS­CO. We think this bodes well for CLVS. Pos­i­tive EM­BRA­CA da­ta pro­vides ad­dl. val­i­da­tion for PARPs in breast can­cer, how­ev­er po­ten­tial lack of mean­ing­ful clin­i­cal dif­fer­en­ti­a­tion and hence a cred­i­ble com­pet­i­tive threat by ta­la­zoparib should read through pos­i­tive­ly for CLVS.

Tesaro launched the Phase III BRA­VO study to see how their drug per­formed in a sim­i­lar breast can­cer pop­u­la­tion, but not­ed back in March that it couldn’t serve as a reg­is­tra­tion study af­ter pa­tients bowed out, pre­fer­ring to get a mar­ket­ed PARP rather than chemo. The biotech went on to say that it is study­ing its drug in com­bi­na­tion with a check­point ther­a­py in breast can­cer.

Im­age: Shut­ter­stock

Charles Nichols, LSU School of Medicine

Could psy­che­delics tack­le the obe­si­ty cri­sis? A long­time re­searcher in the field says his lat­est mouse study sug­gests po­ten­tial

Psychedelics have experienced a renaissance in recent years amid a torrent of preclinical and clinical research suggesting it might provide a path to treat mood disorders conventional remedies have only scraped at. Now a preclinical trial from a young biotech suggests at least one psychedelic compound has effects beyond the mind, and — if you believe the still very, very early hype — could provide the first single remedy for some of the main complications of obesity.

Deborah Dunsire. Lundbeck

UP­DAT­ED: Deb­o­rah Dun­sire is pay­ing $2B for a chance to leap di­rect­ly in­to a block­buster show­down with a few of the world's biggest phar­ma gi­ants

A year after taking the reins as CEO of Lundbeck, Deborah Dunsire is making a bold bid to beef up the Danish biotech’s portfolio of drugs in what will likely be a direct leap into an intense rivalry with a group of giants now carving up a growing market for new migraine drugs.

Bright and early European time Monday morning the company announced that it will pay up to about $2 billion to buy Alder, a little biotech that is far along the path in developing a quarterly IV formulation of a CGRP drug aimed at cutting back the number of crippling migraines patients experience each month. In a followup call, Dunsire also noted that the company will likely need 200 to 250 reps for this marketing task on both sides of the Atlantic. And analysts were quick to note that the dealmaking at Lundbeck isn’t done, with another $2 billion to $3 billion available for more deals to beef up the pipeline.

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Tower Bridge in London [Shutterstock]

#UK­BIO19: Join GSK’s Hal Bar­ron and a group of top biotech ex­ecs for our 2nd an­nu­al biotech sum­mit in Lon­don

Over the past 10 years I’ve made a point of getting to know the Golden Triangle and the special role the UK biopharma industry plays there in drug development. The concentration of world class research institutes, some of the most accomplished scientists I’ve ever seen at work and a rising tide of global investment cash leaves an impression that there’s much, much more to come as biotech hubs are birthed and nurtured.

It’s fi­nal­ly over: Bio­gen, Ei­sai scrap big Alzheimer’s PhI­I­Is af­ter a pre­dictable BACE cat­a­stro­phe rais­es safe­ty fears

Months after analysts and investors called on Biogen and Eisai to scrap their BACE drug for Alzheimer’s and move on in the wake of a string of late-stage failures and rising safety fears, the partners have called it quits. And they said they were dropping the drug — elenbecestat — after the independent monitoring board raised concerns about…safety.

We don’t know exactly what researchers found in this latest catastrophe, but the companies noted in their release that investigators had determined that the drug was flunking the risk/benefit analysis.

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Ac­celeron drops a de­vel­op­ment pro­gram as #2 drug fails to spark func­tion­al ben­e­fits in pa­tients with a rare neu­ro­mus­cu­lar ail­ment

Acceleron is scrapping a muscular dystrophy development program underway for its number 2 drug in the pipeline after pouring over some failed mid-stage secondary data.

Gone is the ACE-083 project in patients with facioscapulohumeral muscular dystrophy. Their drug hit the primary endpoint on building muscle but flopped on key secondaries for functional improvements in patients, which execs felt was vital to the drug’s success.

Scott Gottlieb, AP Images

Scott Got­tlieb has a new board po­si­tion to add to the re­sume — and this one is fo­cused on a fa­vorite sub­ject

Scott Gottlieb has another position to add to his lengthy roster of boards and advisory roles in the wake of his departure from the helm of the FDA.

He’ll be joining the advisory board of FasterCures, a think tank which former junk bond king Michael Milken set up to help drive more drugs to the market, looking to accelerate drug R&D. That’s a subject close to the heart of Gottlieb, who blazed a trail at the FDA focused on hustling up the process. That helped endear him to the industry, making him one of the most popular commissioners in FDA history.

It’s also likely to be a much less controversial post than his board position at Pfizer, which stirred criticism from Democratic presidential candidate Elizabeth Warren.

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Karyopharm lines up $150 mil­lion cash in­jec­tion to back con­tro­ver­sial drug launch

Karyopharm has entered into a royalty agreement worth up to $150 million to back the launch of their multiple myeloma drug — recently approved by the FDA over the objections of a majority of the agency’s outside experts.

The deal with HealthCare Royalty Partners, worth $75 million now and $75 million once certain regulatory and commercial milestones have been reached, will fund the commercialization of Karyopharm’s oral SINE compound Xpovio (selinexor) for patients with multiple myeloma who have already had at least four prior therapies. The money will help Karyopharm as it markets its newly approved drug and pushes through clinical trials testing the drug on refractory multiple myeloma patients with one to three therapies and patients with treatment-resistant diffuse large B-cell lymphoma. It will give Karyopharm a cushion through mid-2021.

Af­ter a run of CT­LA-4 com­bo fail­ures, sci­en­tists spot­light a way to make it work — in se­lect pa­tients

CTLA-4/PD-(L)1 combinations have been one of the El Dorados of oncology, its promise forever behind that next hill but apparently unattainable after a series of pivotal clinical failures. But researchers at New York’s Memorial Sloan Kettering Cancer Center and the Technical University of Munich think they may know how to fix what’s wrong and boost the drive to next-gen cancer combos.

In a preclinical animal research program, researchers found that within a cell, checkpoints rely on a specific molecule — RNA-sensing molecule RIG-I — to work. If that sounds familiar, it’s because it has already been identified as a target for boosting immune responses and was subject to at least one Phase I/II trial. Pfizer in December allied itself with Kineta with $15 million upfront and $505 million in potential milestones to develop RIG-I immunotherapies, and three years ago Merck purchased German upstart Rigontec for $137 million upfront and over $400 million in potential milestones for the same purpose.

Pur­due Phar­ma files for bank­rupt­cy as first step in $10B opi­oid set­tle­ment

It’s settled. Purdue Pharma has filed for bankruptcy as part of a deal that would see the OxyContin maker hand over $10 billion in cash and other contributions to mitigate the opioid crisis — without acknowledging any wrongdoing in the protracted epidemic that’s resulted in hundreds of thousands of deaths.

The announcement came two weeks after news of a proposed settlement surfaced and largely confirm what’s already been reported.